FDA's Advice to Patients

Patients taking Revatio who experience sudden hearing loss should continue
taking their medication but should contact their doctor for further
evaluation.

Because Revatio is used to treat a potentially life-threatening condition,
the FDA doesn't recommend that patients abruptly stop taking the drug.

Reason for Label Change

In April, the Journal of Laryngology & Otology published a case
report of a man who experienced sudden hearing loss while taking Viagra.

After learning of that case, the FDA searched its database of reported
adverse events for instances of hearing loss with Viagra-like drugs.

The FDA found 29 reports of sudden hearing loss -- both with and without
ringing in the ears, vertigo, or dizziness -- in men taking Viagra, Cialis, or
Levitra. Hearing loss was also reported in a few patients in clinical trials of
these drugs.

There have also been cases of hearing loss reported in patients using
Revatio, according to the FDA.

In most of the cases, the hearing loss involved one ear. The hearing loss
was either a partial or complete loss of usual hearing.

In about one-third of the reported cases, hearing loss was
temporary.In the rest of the cases, hearing loss was ongoing at the time
of the report or the final outcome wasn't described in the report.

Viagra, Levitra, and Cialis haven't been proven to cause hearing loss, but
the alert was warranted due to "the strong relationship between the use of
these drugs and sudden hearing loss in these cases," states the FDA.